Movilitas.Cloud, developed by Engineering Industries eXcellence, is a cutting-edge Software-as-a-Service (SaaS) platform designed to make product serialization, tracking and tracing easy.
From FDA DSCSA to Global Reach
“We partnered with Engineering Industries eXcellence as far back as 2003 and again in 2016 to meet FDA DSCSA requirements. With their support, we’ve implemented end-to-end serialization — now live in the U.S., EU, Saudi Arabia, UAE, and Bahrain”
Brian Merriam, Director of IT, Hikma Pharmaceuticals
The DSCSA Enhanced Drug Distribution Security Act requires that transaction information must include the unique product identifier at the package level for all the packages included in the transaction. In addition, trading partners need to have systems and processes in place to promptly respond with the transaction information and transaction statement for a product, upon a request by an Authorized Trading Partner or the FDA. This request supports the verification or investigation of suspects or illegitimate products.
As we are part of the HDA VRS Provider Network we are in close relationship with all shifting regulations. Our expert team is always up to date and has key insights into details of DSCSA.
The U.S. life sciences market has specific regulatory challenges outlined by the FDA to protect public health. The U.S. Drug Supply Chain Security Act (DSCSA) defines a system with a timeline for reaching full item traceability. Each stage requires different levels of compliance by stakeholders.
